# FDA 483 - Reveragen Biopharma Inc. - March 06, 2023

Source: https://www.keypedia.com/records/483/reveragen-biopharma-inc/40f6e473-95c5-44c2-91fd-aa14a51e052a

> FDA 483 for Reveragen Biopharma Inc. on March 06, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Reveragen Biopharma Inc.
- Inspection Date: 2023-03-06
- Product Type: drugs
- Office Name: Office of Regulatory Affairs
- Summary: An FDA inspection of Reveragen Biopharma Inc. in Rockville, MD, identified significant issues as a sponsor of a clinical study. Observations included the failure to address an investigator's non-compliance with investigational product retention protocols, leading to lost study medication without documented corrective actions. Additionally, the firm shipped investigational new drugs to an unauthorized individual not listed on the site's delegation log.

## Related Officers

- [Glenn B Mannheim](https://www.keypedia.com/people/glenn-b-mannheim/214abb55-60b0-497f-a588-6ef3a42dd2da)
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Company: https://www.keypedia.com/companies/reveragen-biopharma-inc/eaf70eaf-05c9-4025-b737-094553dcf19f

Office: https://www.keypedia.com/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64